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Pharmacovigilance and Risk Management Strategies Conference

Mid-Day Keynote

    Session Chair(s)
      Simone  Pinheiro, PhD

      Simone Pinheiro, PhD

      • Lead Epidemiologist
      • FDA, United States
    The FDA is committed to facilitating rapid development, review and action on promising cancer treatments. This exciting DIAmond session will discuss recent progresses and novel approval pathways for oncology therapeutic products, including real world evidence. This session will also discuss the Oncology Center of Excellence, developed as part of the 21st Century CURES Act, and its role in the development of regulatory approaches to expedite drug development. This 45-min session will be composed of two presentations followed by Q&A.
      Sean  Khozin, MD, MPH

      Novel Approaches in Oncology Products

      Sean Khozin, MD, MPH

      • Associate Director (Acting), Oncology Center of Excellence
      • FDA, United States
      Tamy  Kim, PharmD

      Oncology Center of Excellence

      Tamy Kim, PharmD

      • Associate Director for Regulatory Affairs, OHOP and OCE (Acting), CDER
      • FDA, United States